Fort Worth, TX (PRWEB) June 11, 2012
Ethicon Inc., a unit of Johnson & Johnson, plans to stop production of vaginal mesh implants amidst more than a thousand pending lawsuits. J&J said its decision is not related to the lawsuits, but rather “concerns and questions” that have arisen regarding the device’s commercial viability.
The decision follows a letter by the U.S. Food and Drug Administration in January. It ordered 35 manufacturers of surgical mesh implants to conduct new safety studies after the FDA had received more than 1,500 reports of complications from 2008 to 2010, including instances where the devices had eroded into the vagina or caused bleeding and infection.
A J&J spokesman, Matthew Johnson, explained that the company has requested permission from the FDA to halt selling four of its mesh products within the next four months. It then plans to stop global sales of the product within the next three to nine months.
The company said its decision would omit it from being required to conduct the additional safety studies, although it will continue to notify the FDA of complaints or adverse effects from the devices.
Though most devices can get FDA approval under a special process known as 510(k), which allows the device to be sold if the manufacturer can prove it is substantially similar to products already being sold on the market, the company began selling the Prolift mesh in 2005 and did not formally apply for the FDA 510(k) approval until 2007.
The surgical mesh is implanted in women to repair the tissue holding a woman’s pelvic organs when it becomes weak or stretched and bulges into the vagina, a condition known as pelvic organ prolapse (POP). The device is also used to help patients with a severe overactive bladder known as stress urinary incontinence.
In 2010, around 75,000 women received the mesh implants for POP related needs and 200,000 for stress urinary incontinence.
Parker McDonald law firm continues to track news about these harmful products and support the victims of faulty products. It is crucial that patients who have received a vaginal mesh implant seek the advice of a physician because they may be at risk. With ongoing litigation against Ethicon Inc., those who have experienced complications may be entitled to compensation. If you or someone you love had or have complications from a vaginal mesh implant, contact us for more information.
Information referred to in this release was provided by Reuters.
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